HOFCARE Dengue NS1 Ag/IgG/IgM Combo Rapid Test

Main Components: Dengue NS1: Sample pad, colloidal gold conjugate pad, nitrocellulose membrane, absorbent pad, PVC board. Colloidal gold conjugate pad labeled with anti-Dengue NS1 antibody 1, nitrocellulose membrane coated with anti-Dengue NS1 antibody 2, control line coated with goat anti-mouse IgG antibody.
Dengue IgG/IgM: Sample pad, colloidal gold conjugate pad, nitrocellulose membrane, absorbent pad, PVC board. Colloidal gold conjugate pad labeled with dengue recombinant antigen and Biotinylated BSA, nitrocellulose membrane coated with mouse anti-human IgG antibody (T1) and mouse anti-human IgM antibody (T2), control line coated with streptavidin-conjugated IgG.
Sample diluent: Phosphate containing buffer.
Disposable plastic straws (optional).
Description: Different components of different batches cannot be used at the same time to avoid erroneous results.
Material Needed But Not Provided: Timer.
Personal protective equipment, such as protective gloves, medical mask, goggles and lab coat.
Appropriate biohazard waste container and disinfectants.

Performance Characteristics: Clinical trial results: A clinical evaluation was conducted on 400 samples comparing the results obtained using the Dengue NS1 Ag IgG/IgM Combo Rapid Test and Diagnostic Kit for Dengue Virus RNA (RT-PCR Fluorescence Probing). (See Table 1.)

Click on icon to see table/diagram/image

A clinical evaluation was conducted on 400 samples comparing the results obtained using the Dengue NS1 Ag IgG/IgM Combo Rapid Test and Dengue Virus IgG ELISA. (See Table 2.)

Click on icon to see table/diagram/image

A clinical evaluation was conducted on 400 samples comparing the results obtained using the Dengue NS1 Ag IgG/IgM Combo Rapid Test and Dengue Virus IgM ELISA. (See Table 3.)

Click on icon to see table/diagram/image

Explanation of Terms: PPA: Positive Percent Agreement = True Positives/(True Positives + False Negatives).
NPA: Negative Percent Agreement = True Negatives/(True Negatives + False Positives).
OPA: Overall Percent Agreement = (True Positives + True Negatives)/Total CI: Confidence Interval Analytical specificity: Interfering Substances: 1000 μmol/L bilirubin, 5.65 mmol/L triglyceride, 6.5 g/L hemoglobin have no effect on the test result. The reagent is not affected by the antinuclear antibodies and anti-mitochondrial antibodies.
Cross-reactivity: By testing HBV, HAV, HCV, HIV antibody there are no effect on the test result.

The Dengue NS1 Ag/IgG/IgM Combo Rapid Test is a rapid chromatographic immunoassay reagent for the qualitative detection of dengue IgG and IgM antibodies and NS1 antigen in serum, plasma and whole blood to aid in the diagnosis of dengue viral infection.

Test Principle: Dengue NS1: In this test procedure, anti-Dengue NS1 antibody 2 is coated in the test line region (T). After a serum or plasma sample is placed in the sample well, it reacts with anti-Dengue NS1 antibody 1 labeled particles that have been applied to the colloidal gold conjugate pad. This mixture moves chromatographically along the length of the test strip and interacts with the coated anti-Dengue NS1 antibody 2. If the sample contains dengue virus NS1 antigen, a colored line will appear in the test line region (T) indicates a positive result. If the sample does not contain dengue virus NS1 antigen, a colored line will not appear in the test line region (T) indicates a negative result.
To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of sample has been added and membrane wicking has occurred.
Dengue IgG/IgM: When the sample contains the Dengue IgG or/and IgM antibody, it forms a complex with the colloidal gold labeled dengue recombinant antigen. The complex moves forward under the action of chromatography and combines with the mouse anti-human IgG or/and IgM antibody which coated at the T1 (IgG) or/and T2 (IgM) line to form a colored line (T1 or/and T2 line), indicates a positive result. When the sample does not contain the Dengue IgG or/and IgM antibody, no complex can be formed at the T1 or/and T2 line, and no colored line appears, which indicates a negative result.
Regardless of whether the Dengue IgM or/and IgG antibody is contained in the sample, the colloidal gold labeled Biotinylated BSA will bind with the coated streptavidin-conjugated IgG antibody at the C line to form a colored line (C line).
Sample Requirement: 1. The reagent can be used for the serum, plasma and whole blood samples.
2. Serum, plasma and whole blood samples must be collected in a clean and dry container. EDTA, sodium citrate, heparin can be used as the anticoagulants. Recommend to detect immediately after collecting blood. If blood coagulation occurs, serum sample is suggested to use.
3. Serum and plasma samples may be stored at 2-8°C for 1 week prior to assay, and at -20°C for 2 years. Frozen and refrigerated samples should be equilibrated to room temperature before detection and thoroughly mixed. Repeat freeze and thaw for no more than 3 times. Samples that exhibiting visible precipitates, stink or muddy should not be used.
4. Whole blood sample with anticoagulants may be stored at 2-8°C for 24 hours. It should be used immediately without anticoagulants. DO NOT FREEZE. Mix the sample well by gentle inversion of the tube immediately before testing.
Test Procedure: Instruction for use must be read entirely before taking the test. Allow the reagent to equilibrate to room temperature for 30 minutes (10-30°C) prior to testing. Do not open the inner packaging until ready, it must be used in one hour if opened (Humidity ≤60%, Temp: 10-30°C). Use immediately when the humidity exceed to 60%.
Remove the test panel from the sealed pouch, place it on a clean and level surface with the sample well up.
Dengue NS1: Drop 4 drops (80-100 μL) of serum, plasma or whole blood vertically into the sample well of NS1. If the whole blood sample is thick, add 1 drop (40-50 μL) of sample diluent into the sample well of NS1.
Dengue IgG/IgM: Drop 1 drop (25 μL) of serum, plasma or whole blood vertically into the sample well of IgG/IgM, add 2 drops (80-100 μL) of sample diluent into the sample well of IgG/IgM.
Observe the test results immediately within 15-20 minutes, the results is invalid over 20 minutes.
Note: The diagram is for reference only. See the real object for details. The appearance and color of reagent components may be different from the actual product, which has no effect on normal use.
Result Explanation: Dengue NS1: Positive: Two distinct colored lines appear. One line should be in the control region (C) and the other line should be in the test region (T).
Negative: One colored line appears in the control region (C). No line appears in the test region (T).
Invalid: No colored lines appear or control line fails to appear, indicating that the operator error or reagent failure. Verify the test procedure and repeat the test with a new testing device.
Dengue IgG/IgM: IgG and IgM Positive: Three distinct colored lines appear in the control region (C), the IgG test region (G) and the IgM test region (M), indicating the Dengue IgG and Dengue IgM positive.
IgG Positive: Two distinct colored lines appear. One line should be in the control region (C) and another line should be in the IgG test region (G), indicating the Dengue IgG positive.
IgM Positive: Two distinct colored lines appear. One line should be in the control region (C) and another line should be in the IgM test region (M), indicating the Dengue IgM positive.
Negative: One colored line appears in the control region (C). No line appears in the test region (G and M).
Invalid: No colored bands appear or control line fails to appear, indicating that the operator error or reagent failure.
Limitations: The results of the reagent are only for clinical reference, which is not the only basis for clinical diagnosis and treatment.
Negative result may occur when detecting short-term infected samples or some second time infected samples, indicating that the specific antibodies of Dengue IgM does not exist or the concentration is below the detection limit. Some patients may not produce enough antibodies to be detected in their body within 7-10 days, it may show negative results. For some patients, if the Dengue infection is still suspected, they need to do a new Dengue rapid test 3-4 days later.
It is common to have serological cross-reactions with Flaviviruses (ie, between dengue types 1, 2, 3, 4 and St. Louis encephalitis, West Nile, Japanese encephalitis, yellow fever virus, etc.).
Samples with high concentrations of Rheumatoid factor or Heterophilic antibodies may cause false positive results.
A confirmed diagnosis and treatment should only be made by a physician after all clinical and laboratory findings have been evaluated.
It can not be used for screening the general population, but it can only be used for the screening of patients with clinical symptoms or when there is suspicious exposure.
The continued existed or not existed of antibodies can not be used to determine if the treatment is succeeded or not.
The best time for dengue testing is 6~14 days after the symptom of fever.
Quality Control: There are the test line and control line on the surface of the reagent. Neither the test line nor the control line is visible in the result window before applying a sample. The control line is used for procedural control and should always appear if the test procedure is performed properly and the test reagents of the control line are working.
The appearance of control line (C) is confirmed sufficient sample volume, adequate membrane wicking and correct procedural technique.

For IN VITRO diagnose only.
The test result is invalid over 20 minutes.
The strength of the control line does not indicate the quality problem of the reagent, a test result that is clearly visible demonstrates the reagent is effective.
All samples and reagents should be considered potentially hazardous and handled in the same manner as an infectious agent after use.
Do not use other kinds of quality control sample to test the reagent.

Store in a dry environment at 4-30°C, avoid hot and sunshine, valid for 24 months. DO NOT FREEZE. Some protective measures should be taken in hot summer and cold winter to avoid high temperature or freeze-thaw.

Personal Care

MEDICAL DEVICE - Healthcare Device